Tokyo, Aug. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062590) titled 'A study of the effectiveness and side effects of first-line amivantamab plus lazertinib combination therapy for advanced or recurrent EGFR-mutated non-small cell lung cancer' on Aug. 17.

Study Type: Observational

Primary Sponsor: Institute - Department of Pulmonary Medicine

Condition: Condition - Advanced or recurrent EGFR-mutated non-small cell lung cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - This multicenter prospective observational study aims to evaluate the real-world effectiveness and safety of first-line amivantamab plus lazertinib combination therapy in patients with advanced or recurrent EGFR-mutated non-small cell lung cancer. The study also aims to explore predictors of treatment efficacy and adverse events by investigating associations of patient background factors, gut microbiota, peripheral blood immune cell profiles, the tumor microenvironment, and cancer- and immune-related protein expression in tumor tissue with treatment efficacy and safety. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - Patients aged 18 years or older at the time of informed consent with an ECOG Performance Status of 0-2. Patients with non-small cell lung cancer harboring an EGFR exon 19 deletion or L858R mutation. Patients with unresectable stage III disease, stage IV disease, or postoperative recurrence. Patients with evaluable disease according to RECIST version 1.1. Patients who have not previously received an EGFR-TKI and are scheduled to receive amivantamab plus lazertinib as first-line treatment. Only subcutaneous administration of amivantamab is permitted. Patients who have received sufficient explanation of the study and provided written informed consent of their own free will. Key exclusion criteria - Patients who are considered inappropriate for participation in this study by the treating physician for any other reason. Target Size - 50

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 05 Month 08 Day Date of IRB - 2026 Year 07 Month 14 Day Anticipated trial start date - 2026 Year 07 Month 14 Day Last follow-up date - 2031 Year 04 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071643

Disclaimer: Curated by HT Syndication.